Associate Data Reviewer, QC
About The Position
The Associate Data Reviewer, QC supports the Quality Function within Operations. Areas of support may include GMP data review, incoming quality assurance of drugs and packaging materials, manufacturing quality assurance, validation, quality engineering, training, and regulatory compliance. The role is expected to maintain high quality standards while achieving high levels of efficiency. The position performs routine and STAT reviews of laboratory test data, including on-the-floor and off-the-floor review for low-complexity test methods. It also reviews assays and data-mining projects and archives data. The incumbent is responsible for quality decisions within their functional area, helps ensure that products are consistently manufactured in accordance with AbbVie Quality System requirements and applicable regulations, and supports troubleshooting and resolution of quality compliance issues.
Requirements
- Bachelor’s degree, or at least 2 years of combined experience in manufacturing, QA, QC, or R&D within the pharmaceutical or biologics industry.
- Working knowledge of electronic document management and laboratory information management systems.
- Familiarity with Quality Systems, cGMP, and other applicable regulatory requirements.
- Strong verbal and written communication skills.
Responsibilities
- Perform routine and STAT review of laboratory test data, including on-the-floor and off-the-floor review for low-complexity test methods.
- Complete review of assays and data-mining projects, and archive data.
- Handle quality assurance and quality control activities related to the assigned functional area.
- Help ensure products are consistently manufactured in conformance with AbbVie Quality System requirements and applicable regulatory requirements.
- Support troubleshooting and resolution of quality compliance issues.
- Communicate with management regarding Quality Management Review and Quality Initiatives.
- Make quality decisions within the functional area to ensure compliance with AbbVie Quality Systems and cGMPs.
Benefits
- Paid time off, including vacation, holidays, and sick leave.
- Medical, dental, and vision insurance for eligible employees.
- 401(k) for eligible employees.
- Eligibility to participate in short-term incentive programs.
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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
